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普拉克索、培高利特和安慰剂对帕金森震颤影响的随机、双盲、3个月平行研究。

Randomized, double-blind, 3-month parallel study of the effects of pramipexole, pergolide, and placebo on Parkinsonian tremor.

作者信息

Navan Prithiva, Findley Leslie J, Jeffs Jim A R, Pearce Ronald K B, Bain Peter G

机构信息

Division of Neurosciences & Psychological Medicine, Imperial College London, Charing Cross Hospital Campus, London, United Kingdom.

出版信息

Mov Disord. 2003 Nov;18(11):1324-31. doi: 10.1002/mds.10538.

DOI:10.1002/mds.10538
PMID:14639675
Abstract

We compared the antitremor effect of pramipexole, pergolide, or placebo in Parkinson's disease (PD). A double-blind, randomly controlled, parallel protocol was deployed to examine the effects of placebo, pergolide, and pramipexole [doses escalated to 1.5 mg three times daily (t.i.d.) over 3 months] on a compound Tremor Index (TI) and Unified Parkinson's Disease Rating Scale (UPDRS) part III. Thirty PD patients (19 men, 11 women; mean age 69 years, range 54-80 years; mean disease duration 3.9 years, range, 0.5-10 years) participated in the study, with 10 patients in each arm. Six subjects failed to complete the study (4 on pergolide and 2 on placebo). Analysis of covariance demonstrated strong evidence for a treatment effect on both TI and UPDRS III. There was no significant difference between the active treatments on either TI or UPDRS III. Both pergolide and pramipexole were significantly better than placebo. The results indicate that pergolide and pramipexole (1.5 mg t.i.d.) have similar anti-PD tremor and UPDRS III actions that are significantly superior to placebo. Patients on pergolide were more likely to drop out because of adverse events than those on pramipexole.

摘要

我们比较了普拉克索、培高利特或安慰剂对帕金森病(PD)的抗震颤作用。采用双盲、随机对照、平行方案,研究安慰剂、培高利特和普拉克索[剂量在3个月内逐步增加至每日3次,每次1.5毫克(t.i.d.)]对复合震颤指数(TI)和统一帕金森病评定量表(UPDRS)第三部分的影响。30例帕金森病患者(19例男性,11例女性;平均年龄69岁,范围54 - 80岁;平均病程3.9年,范围0.5 - 10年)参与研究,每组10例。6名受试者未完成研究(4例服用培高利特,2例服用安慰剂)。协方差分析表明,治疗对TI和UPDRS III均有显著效果。两种活性治疗药物在TI或UPDRS III方面无显著差异。培高利特和普拉克索均显著优于安慰剂。结果表明,培高利特和普拉克索(每日3次,每次1.5毫克)具有相似的抗帕金森病震颤作用和对UPDRS III的作用,且显著优于安慰剂。与服用普拉克索的患者相比,服用培高利特的患者因不良事件退出研究的可能性更大。

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